1. Field of the Invention
The present invention relates to devices for prevention of involuntary urination, in particular devices comprising a body for arrangement in the vagina for compressive action on and support of the neck of the bladder, combinations of such devices and applicators for use in insertion of the devices into the vagina and methods of manufacturing such devices.
2. Description of the Related Art
The present invention relates to a device for prevention of involuntary urination in a female, comprising a body for arrangement in the vagina for compressive action on and support of the neck of the bladder and optionally the urethra, in which the body has a substantially elongated shape with a longitudinal axis extending, in the intended direction of insertion, from a proximal to a distal end, and in which the body is made from a compressive and elastically deformable material.
Stress incontinence is a nuisance experienced by up to a third of all women at some time or other during their lives.
Stress incontinence is often due to hypermobility of the bladder neck because of insufficient support thereof. Treatments of stress incontinence are aimed at improving the closure of the urethra by better support of the pelvis.
Severe cases of stress incontinence are normally relieved by surgical intervention, while less severe cases of stress incontinence can often be fully or partially relieved by training or retraining of the pelvic musculature.
Training or retraining of a pelvic muscle may, however, extend over many months, and as mentioned, may not in all cases relieve the problem completely.
Thus, there is still a need to find a product which can relieve stress incontinence. The use of sanitary towels and napkins for relieving the inconveniences connected with involuntary urination is generally known. This, however, is a method associated with great disadvantages for the woman, as the sanitary towels are unhandy and voluminous, among other things.
Furthermore, it is known that stress incontinence may be relieved by the use of a tampon-like device which is arranged in the vagina for compressive action and support of the neck of the bladder.
Such a device for relief of stress incontinence is discussed in, for example, U.S. Pat. No. 4,019,498. This device consists of a body of compressible elastic material in the form of a mushroom which is compressed and then placed in a bag. The bag with the body is inserted in the vagina, whereupon the bag is punctured. The body will then press against the neck of the bladder and support this. This method partly involves a cost-increasing componentxe2x80x94the bagxe2x80x94and partly there is a risk of damaging the vagina and adjacent tissue when puncturing the bag. The device excerts sufficient pressure on the anterior wall of the vagina to close the urethra and the woman has to remove the device when she has to urinate. Removing of the device is facilitated by the stem portion of the mushroom which is projecting toward the vagina opening.
Furthermore, it is impossible or difficult to adjust the position of the body after the placing in the vagina. Additionally, the body acts purely by the compressibility of the material, for which reason it is necessary to manufacture it in several sizes.
EP-A-363421 also describes a device for arrangement in a woman""s vagina with the object of relieving incontinence. This device also has the disadvantage that it acts as a support of the bladder neck merely in consequence of the compression taking place depending on the size of the vagina and the size of the body. It is therefore also in this case necessary to manufacture different sizes to compensate for the different vaginal diameter.
Still further, EP-A-264258 describes an incontinence devicexe2x80x94specifically for use in vaginal and rectal prolapsexe2x80x94designed as a U-shaped body, which acts by lifting the neck of the bladder, as, after being arranged, the body returns to its rest position, and one leg of the U bears against the bladder neck of the bladder, which is lifted, whereby continence is obtained. This is thus a relatively rigid structure which is also designed in rather large dimensions.
This device, as well, is required to be manufactured in several different sizes to compensate for the different vaginal diameters, as its lift is exclusively due to its shape, just as it is uncomfortable to wear owing to its rigid and fairly large structure.
A common feature of the above incontinence products is thus that it is necessary to manufacture the product in many different sizes to compensate for the various vaginal diameters.
This is partly economically inappropriate and partly the body will not have an optimum function even after careful selection of size according to a woman""s vaginal diameter, as the support by the bodies of the bladder neck will vary according to the physical posture of the woman and the state of tension of her pelvic muscle. There is thus a great risk that by use of the above mentioned devices, the woman will suffer from involuntary urination, and/or that the device will cause inconvenience, cause pain or even damage the vaginal mucous membrane when the woman is in physical movement or tightens her pelvic musculature.
Thus, the above-mentioned devices are economically unsuitable, just as they do not have an optimum function throughout their service life.
Published international application No. WO95/05790 discloses a device having a body comprising two or more legs which are joined in a flexible base. The body of the device is inserted into the vagina in an elastically deformed state with the legs bent in a direction towards each other. Due to the compressive and elastic properties of the body in combination with its properties of restitution deriving from the deformation of the legs, the device will provide support for the bladder neck without blocking the urethra for varying spatial conditions in the vagina.
Although this known device alleviates the drawbacks of the above-mentioned devices, it still has rather large dimensions and furthermore, the two-legged design has a risk of improper placement during insertion.
It is the object of the present invention to provide an improved device of the kind mentioned in the introduction, which comfortably relieves the nuisances indicated and thus secure the woman an optimum support regardless of her physical condition and which is at the same time easy to handle. Just as important, the woman shall be able to urinate normally without having to remove the device. Eventually, the device should be easy to manufacture.
The present invention relates, in its broadest aspect, to a device for prevention of involuntary urination in a female, comprising a body for arrangement in the vagina for compressive action on and support of the neck of the bladder and optionally the urethra, in which the body has a substantially elongated shape with a longitudinal axis extending, in the intended direction of insertion, from a proximal to a distal end, and in which the body is made from a compressive and elastically deformable material, said device being characteristic in that the body comprises at least one part protruding from the outer surface of the body and providing at least one pressure area for contact with the neck of the bladder and optionally the urethra and in that the body is provided with at least one string extending from the distal end.
The protruding part(s) ensure a higher pressure during movements and thereby a better support of the neck of the bladder. The device seems relatively small and appealing to the user although it performs the same pressure as larger and already known products. Also it assures that no involuntary urination will occur while at the same time voluntary urination is possible.
The device according to the invention for prevention of involuntary urination in a female may be symmetric with respect to the longitudinal axis of the body, preferably axisymmetric. Symmetric and in particularly axisymmetric products have the advantage that the body need not be oriented at insertion. Additionally, symmetric products are generally easier and cheaper to manufacture and therefore economically appropriate, especially for disposable products.
The protruding part or parts may in an embodiment protrude from the body circumferentially, substantially perpendicular to the longitudinal axis of the body. It is difficult to define the size and height of the protruding part(s) as these measures depend on the chosen material but the protruding part(s) has to be so elevated above the adjecent lower parts and has to cover an area adequatly big in order to produce an increased pressure against the bladder neck. The pressure should be increased when compared to the pressure performed by a cylindric body with a diameter equal to the cross section in the lower adjecent part(s). On the other hand the area covered by the protruding part(s) can not be to big as this will increase the material consumption, affect the user-appeal of the product and could possibly spoil the ability to urinate voluntarily.
Exactly how elevated and how big a certain area of a protruding part should be depends mainly on the elasticity of the chosen material.
How far away the protruding part(s) should be placed from each other also partly depends on the material but as a guideline the adjecent low areas should have a width of at least 3 mm preferably of at least 5 mm measured halfway between the top of a protruding part and the bottom of a low adjecent part.
In order to facilitate removal of the device after use, the body is provided with at least one string projecting from the distal end of the body.
In a further development of this embodiment, there are two or more, e.g. three, protruding parts with adjecent low part(s) formed as a narrowed waist(s) between them.
In another embodiment, there are at least two protruding parts extending substantially parallel to the longitudinal direction of the body. The adjecent low area between the longitudinally protruding parts makes a xe2x80x9ccradlexe2x80x9d which fits the neck of the bladder not only at the bottom, but also along the sides and provides an optimum support.
The body may have a substantially conical or frusto-conical shape, which provides for a reliable support of the neck of the bladder and possibly the urethra. The base of the cone or the frustum may correspond to the distal end of the body, i.e. the end facing outwards in the position of use, which facilitates insertion of the device. In a preferred embodiment, however, the base of the conical or frusto-conical body corresponds to the proximal end thereof. By this design, forces acting on the device due to sudden movements of the user, such as sneezing, coughing and jumping, will be transferred into one transverse and one longitudinal component. The latter component will prevent the device from being pressed out of the vagina.
The body of the device may be formed in a traditional, hydrophilic material, such as polyurethane or polyvinyl alcohol, in which case the device has to be wetted before use, but in a preferred embodiment the body is formed in a hydrophobic material, preferably hydrophobic polyurethane. The use of a hydrophobic material instead of a hydrophilic material that needs to be soaked in water or the like before use has the advantage that the woman is free to apply the device any place she wants without the need of water. Further it reduces the risk of infection caused by water of poor quality.
The material is preferably porous.
In a further aspect the invention relates to the combination of a device for prevention of involuntary urination in a female and an applicator for use in the insertion thereof into the vagina.
The applicator is characteristic in that it comprises an elongated member for abutment with at least the distal end of the body of the device during the insertion. The elongated member of the applicator will protrude from the vagina during the insertion and secures that a reliable positioning of the device may take place with minimum manual contact with the device.
Also the employment of the applicator reduce the circumference of the device at the time of insertion which make the device even more appealing to the female users. Normally the maximum sectional area of the body will be reduced by at least 50% when the applicator is employed.
In its simplest form, the applicator comprises one substantially rod-shaped end portion for abutment with an indentation in the distal end of the body of the device.
In order to indicate the correct depth of introduction, the applicator may at the other end portion comprise marks.
In a preferred embodiment, the elongated member of the applicator comprises a piston-like element, which fits into a substantially tubular part.
The tubular part may be open at both ends and define a cavity for accommodating the device in a compressed and elastically deformed state.
Alternatively, the elongated member of the applicator comprises a tubular part and accommodates the device in a compressed and elastically deformed state.
In the case of devices made from a hydrophobic material, which do not have to be soaked before use, the preferred combination of a device and an applicator comprising at least one tubular part for accommodating the body of the device in a compressed and elastically deformed state is particularly advantageous, as the device and the applicator may be delivered as a ready-to-use unit, e.g. in hygienic one-piece packagings.
Still further the invention relates to a method of manufacturing a device for prevention of involuntary urination in a female.
The method comprises the steps of mixing the components of the material, injecting the material into a mould, optionally accelerated hardening by heating the mould, and removing the body from the mould.
At some stage of the manufacturing process, at least one string is fastened to the body.
In a preferred embodiment, the string is fastened to at least one portion of the mould prior to the injection of the material into the mould. This provides for an easier and cheaper production in comparison with traditional methods, in which the string has to be sewn into the body of the device after the removal of the body from the mould, which is a time-consuming operation.